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It is intended for management of pruritus and Dryness of skin in Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.

Derma-R Cream is a non-sterile formulation intended for topical application. It is intended for management of pruritus and Dryness of skin in Atopic dermatitis and Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.

This FDA 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a summary for a cream (Derma-R Cream), not a software or AI-driven medical device. Therefore, it does not include the requested details regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document indicates that "No clinical performance testing was provided to demonstrate device safety and effectiveness." Instead, the submission relies on the comparison of the Derma-R Cream's formulation and non-clinical testing results (biocompatibility, microbiology, stability) to a predicate device (Neosalus cream) to establish substantial equivalence.

Therefore, I cannot provide a response based on the provided input for any of the requested criteria, as they are not applicable to the type of device and submission described.

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